Bioanalytical Method Validation Reports Clause Samples
The Bioanalytical Method Validation Reports clause requires the preparation and provision of detailed reports documenting the validation of analytical methods used to measure biological samples in a study. These reports typically include information on the accuracy, precision, sensitivity, and reproducibility of the methods, and may outline the procedures, results, and any deviations encountered during validation. By mandating such documentation, the clause ensures that all analytical methods are reliable and meet regulatory standards, thereby supporting the integrity of study data and facilitating regulatory submissions.
Bioanalytical Method Validation Reports. Doc #6229 - Determination of TP-0239 in Mouse, Rat, and Monkey Plasma Doc #9160 - Determination of TP-0239 in Human Plasma (Report No. V-00-TP0239-01) Doc #9101 - Determination of Clevudine in Human Urine (Report No. V-00-TP0239-02) Doc #14893 - Determination of Clevudine in Rabbit, Rat, and Mouse Plasma (Report No. V-02-BIO-TP0239-01) Doc #9962 - Determination of D-FMAU Plasma Concentrations in Support of Protocol FMAU-101 (Report No. ▇-▇▇-▇▇▇-▇▇▇▇▇▇-▇▇) ▇▇▇ #▇▇▇▇▇ - Determination of D-FMAU Human Urine Concentrations in Support of Protocol FMAU 101 (Report No. ▇-▇▇-▇▇▇-▇▇▇▇▇▇-▇▇) ▇▇▇ #▇▇▇▇▇ - Determination of D-FMAU Feces Concentrations in Support of Protocol TTAQ-107 (Report No. R-01-BIO-TP0268-02) Doc #6404, Clevudine Drug Substance,TP-0239-99041 Doc #7481, Internal Standard for ▇-▇▇▇▇,▇▇-▇▇▇▇-▇▇▇▇▇ ▇▇▇ #▇▇▇▇, ▇▇▇▇▇▇▇▇▇ Primary Reference ▇▇▇▇▇▇▇▇,▇▇-▇▇▇▇-▇▇▇▇▇ ▇▇▇ #▇▇▇▇, 14C- Radiolabeled Drug Substance,TP-0239-00118 Doc #1039, Synthetic Intermediate of Clevudine, Route 1,TP-0345-00199 Doc #13685, Clevudine Drug Substance,TP-0239-01100 Certificates of Analysis, Drug Product: Doc #13013, Clevudine Capsules, 10 mg,TP-0239-01116 Doc #13014, Clevudine Capsules, 50 mg,TP-0239-01117 Doc #13015, Clevudine Capsules, 5 mg, GMP,TP-0239-01115 Doc #13019, Placebo to Match Clevudine Capsules, 5,10, and 50 mg,TP-0286-01114 • The current inventory of pharmacokinetic samples includes. L-FMAU-101 1296 samples L-FMAU-102 1176 samples L-FMAU-102B 2004 samples L-FMAU-104 1584 samples * Please be advised that due to the language within each study-specific Informed Consent Form addressing sample storage and/or confidentiality, these samples must remain under the control of Gilead and can not be transferred to Bukwang. NIH study 151 samples Duck study 38 samples TOX 042 144 samples TOX 043 200 samples TOX 045 1311 samples TOX 046 790 samples TOX 065 124 samples TOX 066 90 samples TOX 111 191 samples TOX 112 183 samples TOX 130 88 samples TOX 131 91 samples TOX 143 215 samples